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510(k) K880399

V-TREND IM DRY-SPOT TEST by Texas Immunology, Inc. — Product Code KTN

K880399 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND IM DRY-SPOT TEST". The FDA issued a decision of Substantially Equivalent on Feb 17, 1988. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 17, 1988
Date Received
Jan 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
Review Panel
MI
Submission Type

Other clearances by Texas Immunology, Inc.

  • K991465 — DRUG STOP (Dec 10, 1999)
  • K980153 — DRUG CHECK (Mar 27, 1998)
  • K973208 — FIRST SIGN (Oct 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (Jul 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (Feb 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (Jul 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (Oct 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (Apr 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (Feb 17, 1989)

Other clearances for product code KTN

  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (Jun 22, 2018)
  • K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (Feb 28, 2005)
  • K030215 — BIORAPID MONONUCLEOSIS (Feb 24, 2003)
  • K012901 — COLOR-MONOGEN (Sep 27, 2001)
  • K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (Jan 28, 1999)
  • K981946 — CLEARVIEW IM (Dec 10, 1998)
  • K972457 — MONOCOL/LEX-IM TEST (Dec 1, 1997)
  • K972231 — OSOM MONO TEST 143 (Aug 26, 1997)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (Feb 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (Feb 4, 1997)

FDA data resources